InflammationNCT01735773
Role of Prohepcidin in Uremic Patients
An observational study of Inflammation and Chronic Kidney Disease, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Chronic Kidney Disease
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also.
Who may be able to join
- hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
- age between 18-80 years,
- patients with creatinine clearance between 15-30 ml/min.
Who cannot join
- age less than 18 or more than 80,
- diabetic patients,
- current active infectious or inflammatory disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, 34390
About this study
Official title: The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study
The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.
- Conditions
- Inflammation, Chronic Kidney Disease
- Keywords
- hemodialysis, inflammation, iron, peritoneal dialysis, prohepcidin, uremia
- Medical subject headings
- Inflammation, Renal Insufficiency, Chronic, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis group | Patients on chronic hemodialysis program | |
| Peritoneal dialysis group | Patients on chronic peritoneal dialysis program | |
| Pre-dialysis group | Patients with chronic kidney disease stage-4 | |
| Control group | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
prohepcidin level
Prohepcidin levels will be compared with other inflammatory markers.
Measured: Six months
Secondary outcomes (1)
Anemia and inflammatory markers
Correlations of prohepcidin levels with anemia and inflamatory markers
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735773
- Sponsor's protocol ID
- HEPCIDIN-HASEKI
- Status last verified
- Nov 2012
- First submitted
- 26 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study
- ClinicalTrials.gov ID
- NCT01735773
- Acronym / sponsor ID
- HEPCIDIN-HASEKI
- Conditions
- Inflammation, Chronic Kidney Disease
- Keywords
- hemodialysis, inflammation, iron, peritoneal dialysis, prohepcidin, uremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis group | – | –Patients on chronic hemodialysis program |
| Peritoneal dialysis group | – | –Patients on chronic peritoneal dialysis program |
| Pre-dialysis group | – | –Patients with chronic kidney disease stage-4 |
| Control group | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also.
Key inclusion criteria (3 listed)
- hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
- age between 18-80 years,
- patients with creatinine clearance between 15-30 ml/min.
Key exclusion criteria (3 listed)
- age less than 18 or more than 80,
- diabetic patients,
- current active infectious or inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prohepcidin level
Time frame: Six months
Prohepcidin levels will be compared with other inflammatory markers.
1 secondary outcome
Anemia and inflammatory markers
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Chronic Kidney Disease, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prohepcidin level (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.